A Retrospective Evaluation of Adverse Drug Reactions Due to Cancer Chemotherapy in a Tertiary Care Hospital in South India

Abstract

Introduction: To evaluate the adverse drug reactions (ADRs) due to cancer chemotherapy in a tertiary care hospital in South India. Materials and Methods: This was a retrospective descriptive study. The data was obtained from patients who developed, at least, one ADR due to cancer chemotherapy during the period June 2014 to May 2015. The causality of the ADRs were evaluated by WHO-UMC causality assessment system and Naranjo's ADR probability scale, the severity of ADRs were assessed by Hartwig and Siegel ADR severity assessment scale, and preventability of ADRs were determined by the Schumock and Thornton ADR preventability assessment scale. Results: One hundred fourteen ADRs due to cancer chemotherapy were reported in 73 patients. Hyponatremia (20.2%), neutropenia (11.4%), infections of the lung (11.4%), leucopenia (9.6%) were the commonly suspected ADRs. Cisplatin (62.3%), carboplatin (18.4%), cetuximab (3.5%), gefitinib (2.6%) were the commonly suspected medications. As per the WHO-UMC causality assessment system 66(57.8%) ADRs were possible and 48(42.1%) were probable. Naranjo's ADR probability scale showed that 74(64.9%) ADRs were possible and 40 (35.1%) were probable. There was a very good agreement between the two scales (kappa=0.853). All ADRs were classified as level 4 severity barring one. None of the ADRs reported were preventable. Conclusion: Since 80% of the ADRs were suspected to be due to platinum containing anticancer drugs this provides a focus for further research on devising methods for prevention or early detection of ADRs. Prompt detection of ADRs is important to decrease morbidity and mortality.Key words: Adverse Drug Reaction, Cancer Chemotherapy, Naranjo's ADR probability scale, Causality assessment, Pharmacovigilance, WHO-UMC causality assessment system. Correspondence RESULTSOne hundred fourteen ADRs due to cancer chemotherapy were reported in 73 patients during the study period. Among the ADRs reported, 63(55.3%) were in males and 51(44.7%) in females. The mean age of the patients was 55.98 ± 6.53 years in males and 52.96 ± 10.09 years in females. Oropharyngeal malignancy (24.6%) was the most common groups of cancers followed by malignancy affecting the digestive organs (16.7%), female genital organs (15.8%) and breast (7%). Among these, malignancy of cervix uteri (14.9%) and esophagus (14.9%) were the most common cancers. The gender-wise distribution of different malignancies is shown in Table 1. ADRs affecting blood (38.5%) were the most common suspected category of ADR, followed by metabolic abnormalities (29.8%) and infections (15%). Table 2 shows the various ADRs reported in the study population. Hyponatremia (12%), respiratory tract infection (9%) and neutropenia (7%) accounted for 44.4% of the ADRs in males. Hyponatremia (21.6%); neutropenia, diarrhea, anemia (11.8%); leucopenia, thrombocytopenia (9.8%) accounted for 76.6% of the ADRs in females. Seventy-four (64.9%) ADRs were considered to be recovering at the time of reporting, 253 impairing host protective mechanisms...

A Clinical Study of Cutaneous Manifestations in Patients on Cancer Therapy at a Tertiary Care Hospital

“…Our finding is similar to the study carried out by Sharma et al [5] that showed adverse effects in the 41-60 years age group. This finding is also similar to the report of Pai et al [6] who also reported average age of subjects 55.98 years and 52.96 years in men and women respectively and likewise, a study of Behera et al [7] which showed adverse reactions in 41-60 years age group was highest. This can be because of the high occurrence of cancers in this particular age group.…”

Assessment of Adverse Effects of Most Commonly Prescribed Anticancer Drugs in a Tertiary Care Teaching Hospital

“…This was contrary to the findings of Bellare, et al ., (2016) who showed hyponatremia (12%) and infection (9%) as the most common ADR for males and hyponatremia (9.8%), neutropenia (11.8%) in females. 10 The occurrence of neutropenia was very less when compared to other studies. Gastrointestinal and haematological ADRs were frequently observed in the current study which resembles the study done by Thennarasu, et al, (2015).…”

Pattern of Adverse Drug Reactions of Various Chemotherapeutic Agents in Cancer Patients in Kumaun Region

“…Similar results were reported by other studies [12 , 14] Most common cancer diagnosed was Bronchogenic carcinoma 21.53% , Carcinoma breast 18.46% , followed by carcinoma larynx 15.38% and carcinoma cervix 7.69%. This was similar to other studies [12 , 13] Malik et al and Poddar et al have reported lung and breast cancer as the most common [11,15] wheras Sunil Bellare et al reported oropharyngeal cancer as the commonest cancer reported [19] . Surindiran et al reported cervical cancer as the commonest cancer [16] The differences found in our study may be due to variation in geographic regions, food habits and life styles, occupational and environmental conditions Commonest ADR reported in our study were nausea & vomiting 17.11 % .followed by Headache 8.02% , Anxiety and Diziness 6.95 %.…”

“…There was no certain reaction as rechallenge was not done in any of the patient. Good correlation between the two scales of assessment was in agreement with Mittal et al and Sunil Bellary et al [19,20] However few other studies reported poor correlation between the scales [20 , 21] Causality assessment is to some extent subjective , so a definitive inferences may differ between two observer which was commented by other researchers as well [22,23] Hartwig and Siegel scale assessed most of the reactions as "moderate " 62.56% followed by "mild " 34.75% and "severe"2.67% and did not warrant withdrawl of the concerned drugs except in two patients who experienced features of anaphylaxis and were treated accordingly. This was in agreement to a study conducted by Sharma et al [6] None of the drugs caused lethal ADR .…”